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CTRI Number  CTRI/2025/07/091287 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 19/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Changes to foot structure following toe amputation 
Scientific Title of Study   Biomechanical and anthropometric alterations in the foot following toe amputation 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Devesh Joshi 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of General Surgery, 3rd Floor, Smt. Sharada Madhav Pai OPD, Kasturba Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8860385504  
Fax    
Email  devesh.kmcmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Stanley Mathew 
Designation  Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of General Surgery, 3rd floor, Smt. Sharada Madhav Pai OPD, Kasturba Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9844409900  
Fax    
Email  stanley.mathew@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Jithin Abraham 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of General Surgery, 3rd floor, Smt. Sharada Madhav Pai OPD, Kasturba Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9632883146  
Fax    
Email  jithin.abraham@manipal.edu  
 
Source of Monetary or Material Support  
Department of General Surgery, Kasturba Medical College, Manipal 576014, Udupi District, Karnataka State, India  
 
Primary Sponsor  
Name  Dean  
Address  First floor, Administrative Block, Kasturba Medical College, Madhav Nagar, Manipal 576104 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Stanley Mathew  Kasturba Hospital, Manipal  Department of General Surgery, 3rd Floor, Smt.Sharadha Madhav Pai OPD Building, Kasturba Hospital, Manipal - 576104
Udupi
KARNATAKA 		 9844409900

stanley.mathew@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, (2) ICD-10 Condition: E136||Other specified diabetes mellituswith other specified complications, (3) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients who have undergone unilateral toe amputation, at least 6 months prior to index visit
2. Anatomically normal contralateral foot 
 
ExclusionCriteria 
Details  1. Previous surgeries of the foot other than the toe amputation as index procedure
2. Pre-existing musculoskeletal deformity
3. Pre-existing neurological deficits except diabetic neuropathy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Determining differences in anthropometric changes and biomechanical modifications between the amputated and contralateral normal foot

 		 1 week 
 
Secondary Outcome  
Outcome  TimePoints 
1. Documentation of pressure distribution and specific points of high pressure on both the amputated and normal foot in a static podogram
2. Documentation of any complications or adverse outcomes associated with foot health, such as ulcers or callosity in either the amputated foot or contralateral normal foot
 		 1 month 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  All the individual participant data collected during the trial, after deidentification

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response (Others) -  Researchers and journal editors

  4. For what types of analyses will this data be available?
    Response (Others) -  For individual participant data meta analysis

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be shared if written request is made

  6. For how long will this data be available start date provided 01-02-2027 and end date provided 01-02-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Patients who visit the Surgery OPD with a toe amputation done atleast 6 months prior, will be invited to participate in this study. Prior to inclusion, informed consent will be obtained from each participant. The study will involve a comprehensive evaluation of both the amputated and normal foot using various parameters. This includes collecting data available in the EMR or Medical Records available with the patient from an outside hospital, as mentioned in the proforma. The foot is then assessed by measuring bilateral foot circumferences, foot posture, range of motion, height of medial arch, contact area of the foot and eversion / valgus at the ankle joint. Pre and post operative plain x rays of the foot, if available (done by the treating physician or outside hospital) will also be assessed. Pressure points will be identified and compared to those of the normal foot using a static podogram. Sensory and motor deficits will be documented. The data collected from these assessments will be compared with those of the contralateral normal foot.
 
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